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TAP vs QLB in Patients After Cesarean Delivery

Primary Purpose

Cesarean Section, Postoperative Pain

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
TAP (transversus abdominis plane block)
QL (quadratus lumborum block)
Ropivacaine
Needle
paracetamol
metamizole
Ketoprofen
Morphine
Sponsored by
Medical University of Lublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Section focused on measuring transversus abdominis plane block, quadratus lumborum block, neuropathic pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • obtained consent
  • singleton pregnancy
  • subarachnoid anesthesia

Exclusion Criteria:

  • coagulopathy
  • allergy to local anesthetics
  • depression, antidepressant drugs treatment
  • epilepsy
  • usage of painkiller before surgery
  • addiction to alcohol or recreational drugs

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    TAP

    QLB

    Arm Description

    Ultrasound-guided transversus abdominis plane block at the end of cesarean section

    Ultrasound-guided quadratus lumborum block at the end of cesarean section

    Outcomes

    Primary Outcome Measures

    Postoperative pain
    Acute pain measured with VAS (visual-analogue scale). VAS in milimmeters. Minimum value 0, maximum 100. Less better - less severe pain. 0 no pain at all.

    Secondary Outcome Measures

    Neuropathic pain
    Neuropathic pain occurrence assessed with Neuropathic Pain Symptom Inventory (NPSI) 10 descriptive variables, each one from 0 to 10. 0 means no pain. 10 very high chance of occurrence of neuropathic pain.

    Full Information

    First Posted
    January 12, 2018
    Last Updated
    January 19, 2018
    Sponsor
    Medical University of Lublin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03404908
    Brief Title
    TAP vs QLB in Patients After Cesarean Delivery
    Official Title
    Postoperative Analgesia With Transversus Abdominis Plane Block or Quadratus Lumborum Block in Patients After Cesarian Delivery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 7, 2018 (Anticipated)
    Primary Completion Date
    January 14, 2019 (Anticipated)
    Study Completion Date
    April 17, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Lublin

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Comparison of two types of analgesia after cesarean section All patients will be anesthetized with spinal technique. Ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will be measured with visual-analog scale (VAS). 1, 2, 6 months after surgery each patient will be called to assess neuropathic pain with Neuropathic Pain Symptom Inventory (NPSI).
    Detailed Description
    Written consent will be obtained before the cesarean section. Only subarachnoidally anesthetized patients may participate in the study. Pencil-point spinal needle and bupivacaine (Marcaine Heavy Spinal 0.5 %) will be used. At the end of surgery ultrasound-guided regional block will be performed. Each patient will be randomly allocated to one of the treated group: transversus abdominis plane block (TAP) or quadratus lumborum (QL). Patients receive 0.2 mL of local anesthetic solution (0.375 % ropivacaine) on each side. Postoperative pain will be measured with VAS (visual-analog scale) 2, 4, 8, 12 and 24 hours after the end of the operation. Paracetamol, metamizole, ketoprofen may be given as required. Whenever pain exceeds 40 (VAS) 5 mg of morphine will be given intravenously (maximum two dosages per day). 1, 3, 6 months patients will be called to assess neuropathic pain. Neuropathic Pain Symptom Inventory (NPSI) will be used.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cesarean Section, Postoperative Pain
    Keywords
    transversus abdominis plane block, quadratus lumborum block, neuropathic pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Parallel Assignment
    Masking
    Participant
    Masking Description
    Single (Participant)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TAP
    Arm Type
    Experimental
    Arm Description
    Ultrasound-guided transversus abdominis plane block at the end of cesarean section
    Arm Title
    QLB
    Arm Type
    Experimental
    Arm Description
    Ultrasound-guided quadratus lumborum block at the end of cesarean section
    Intervention Type
    Procedure
    Intervention Name(s)
    TAP (transversus abdominis plane block)
    Intervention Description
    the ultrasound-guided regional block of abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375% ropivacaine administered (0.2 mL/kg).
    Intervention Type
    Procedure
    Intervention Name(s)
    QL (quadratus lumborum block)
    Intervention Description
    the ultrasound-guided regional block of abdominal wall muscles to treat acute pain, similar to transversus abdominis plane block, but with a distribution of local anesthetic towards paravertebral space. Stimuplex Ultra 360 needle will be used and 0.25% bupivacaine administered (0.2 mL/kg).
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine
    Intervention Description
    In both groups (TAP&QLB) 0.375% ropivacaine will be given (0.2 mL/kg)
    Intervention Type
    Device
    Intervention Name(s)
    Needle
    Intervention Description
    Ultrasound-guided, Stimuplex ultra 360 needle will be used in the study
    Intervention Type
    Drug
    Intervention Name(s)
    paracetamol
    Intervention Description
    Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
    Intervention Type
    Drug
    Intervention Name(s)
    metamizole
    Intervention Description
    Intravenous metamizole will be used (1.0 gram), up to 4 grams per day
    Intervention Type
    Drug
    Intervention Name(s)
    Ketoprofen
    Intervention Description
    Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day
    Intervention Type
    Drug
    Intervention Name(s)
    Morphine
    Intervention Description
    Intravenous morphine (5 mg) will be given when pain exceeds 40 mm in VAS (maximum 2 doses per day)
    Primary Outcome Measure Information:
    Title
    Postoperative pain
    Description
    Acute pain measured with VAS (visual-analogue scale). VAS in milimmeters. Minimum value 0, maximum 100. Less better - less severe pain. 0 no pain at all.
    Time Frame
    up to 24 hours after the surgery
    Secondary Outcome Measure Information:
    Title
    Neuropathic pain
    Description
    Neuropathic pain occurrence assessed with Neuropathic Pain Symptom Inventory (NPSI) 10 descriptive variables, each one from 0 to 10. 0 means no pain. 10 very high chance of occurrence of neuropathic pain.
    Time Frame
    6 months from the surgery

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    parturients
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: obtained consent singleton pregnancy subarachnoid anesthesia Exclusion Criteria: coagulopathy allergy to local anesthetics depression, antidepressant drugs treatment epilepsy usage of painkiller before surgery addiction to alcohol or recreational drugs
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michał Borys, M.D., PhD
    Phone
    + 48 506350569
    Email
    michalborys1@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Paweł Piwowarczyk, M.D., PhD
    Phone
    +48 511285352
    Email
    piwowarczyk.pawel@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mirosław Czuczwar, M.D., PhD
    Organizational Affiliation
    Medical University of Lublin
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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